NCT00002334已完成3 期
A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 26
研究概览
简要总结
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
详细描述
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Erythropoietin and G-CSF.
- •Concurrent Treatment:
- •Local skin radiotherapy.
- •Patients must have:
- •HIV infection.
- •CD4 count 50 - 350 cells/mm
- •No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
- •No acute serious opportunistic infections requiring immediate treatment.
- •No unexplained fever persisting for 14 days within 90 days prior to study entry.
- •No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry.
- •No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy.
- •Life expectancy of at least 80 weeks.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Malabsorption.
- •Severe chronic diarrhea.
- •Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).
- •Any grade 3 or worse toxicity.
- •Inability to comply with study requirements.
- •Concurrent Medication:
- •Other investigational agents.
- •Antineoplastic agents.
- •Biologic response modifiers (including interferons).
- •Foscarnet.
- •Anti-HIV drugs other than the study drugs.
- •Concurrent Treatment:
- •Radiotherapy (other than local skin radiotherapy).
- •Patients with the following prior condition are excluded:
- •History of non-Hodgkin's lymphoma.
- •Prior Medication:
- •Acute therapy for opportunistic infection within 14 days prior to study entry.
- •Prior HIV proteinase inhibitor.
研究者
研究点 (26)
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